A Point of Care Device for Patients with Oxalurias, the Oxalate Now

About This Grant

Project Summary Kidney stone disease (nephrolithiasis) is a growing public health concern, with a lifetime prevalence of 10– 15% in developed countries. In the United States, the incidence has increased by nearly 70% over the past three decades, now affecting 10.6% of men and 7.1% of women. This rise is linked to dietary changes, climate factors, metabolic disorders, and obesity rates. Calcium oxalate stones account for 75–80% of all kidney stones, with hyperoxaluria—excess urinary oxalate excretion—being the primary risk factor for stone formation and recurrence. The five-year recurrence rate exceeds 50%, leading to severe pain, frequent emergency room visits, and progressive kidney damage. Management of calcium oxalate kidney stones often requires pharmacological interventions aimed at reducing stone formation and recurrence. Common treatment strategies include thiazide diuretics, which lower urinary calcium excretion, and citrate supplements, which bind urinary calcium to prevent calcium oxalate crystal formation. Potassium citrate is frequently prescribed to alkalinize urine and enhance citrate excretion, further inhibiting stone formation. However, the success of these treatments depends on precise monitoring of urinary pH, creatinine, oxalate levels, and Ox/Crea ratios must be carefully managed to optimize therapy and minimize side effects. The economic burden of kidney stones exceeded $2.1 billion, with total economic losses surpassing $5 billion, including lost productivity and disability. Despite the growing medical and economic burden of kidney stone disease, management remains reactive rather than preventive, due primarily to the lack of accessible, real-time urine monitoring solutions. The current standard, 24-hour urine collection, is impractical for routine use because of long turnaround times, cumbersome sample handling, and noncompliance rates exceeding 30%. These limitations delay diagnosis and intervention, increasing stone recurrence risk. The Oxalate Now home monitoring test introduces a real-time, non-invasive solution for monitoring Ox concentration, Crea concentration, Ox/Crea ratio and urinary pH, addressing these limitations. By providing real-time feedback, it allows patients and clinicians to intervene before oxalate levels reach dangerous thresholds. IVDS proposes Oxalate Now will transform patient management by reducing delays, improving diagnostic accuracy, and enhancing patient adherence to treatment regimens. The specific aims of this proposal are: Finalize Detection Formulations, 2) Complete the Oxalate Now Mobile Device App, 3) Analytical Validation of Membrane Formulations, 4) Establish Concordance of Oxalate Now to the Roche Spectrophotometric Assay Using Urine Biobanked Patient Samples.